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Monoclonal Antibodies

Ivonescimab + Pembrolizumab for Lung Cancer

Q: How many hospitals within the U.S. are currently administering this clinical research?

<p>South <a href="https://www.withpower.com/clinical-trials/florida">Florida</a> <a href="https://www.withpower.com/clinical-trials/oncology">Oncology</a> &#x26; Hematology Consultants LLC - Plantation in Plantation, Florida, Park Nicollet Institute in Saint Paul, <a href="https://www.withpower.com/clinical-trials/minnesota">Minnesota</a> and Tranquil Clinical Research in Webster, <a href="https://www.withpower.com/clinical-trials/texas">Texas</a> are amongst the clinical trial sites for this research. There are 4 additional locations as well.</p>

Phase 3

Recruiting

Research Sponsored by Summit Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No prior systemic treatment for metastatic NSCLC

Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 4 years

Awards & highlights

Study Summary

This trial compares the effects of two treatments for metastatic lung cancer on overall survival, progression free survival, response, and safety.

Who is the study for?

Adults with metastatic squamous non-small cell lung cancer (NSCLC) who have not had previous treatments for their advanced disease. Participants must have a certain level of PD-L1 expression, be in good physical condition (ECOG score 0 or 1), and expect to live at least three more months. They cannot join if they have small cell lung carcinoma, non-squamous NSCLC, major blood vessel involvement by the tumor, or known specific genetic alterations.Check my eligibility

What is being tested?

This Phase 3 trial is testing Ivonescimab combined with chemotherapy against Pembrolizumab with chemotherapy as first-line treatment options for metastatic squamous NSCLC. The main goal is to see which treatment helps patients live longer without their cancer getting worse.See study design

What are the potential side effects?

Possible side effects include reactions at the injection site, immune-related issues such as inflammation in various organs due to an overactive immune response, fatigue, and complications related to chemotherapy like nausea and low blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I haven't had any systemic treatment for my advanced lung cancer.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My lung cancer has spread to other parts of my body.

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My lung cancer is confirmed to be squamous type.

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My tumor shows a certain level of PD-L1 expression.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival (OS)

Secondary outcome measures

Adverse Event (AE)

Progression-Free Survival (PFS)

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A - Ivonescimab and chemotherapyExperimental Treatment1 Intervention

Subject will receive ivonescimab and chemotherapy

Group II: Arm B - Pembrolizumab and chemotherapyActive Control1 Intervention

Subject will receive pembrolizumab and chemotherapy

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Summit TherapeuticsLead Sponsor

9 Previous Clinical Trials

1,829 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment currently in search of new participants?

"Evidence from clinicaltrials.gov suggests that this clinical investigation is currently recruiting test subjects, having first been posted on October 26th 2023 and recently amended the following week."

Answered by AI

What potential side effects should patients anticipate with Arm A - Ivonescimab and chemotherapy?

"Our team at Power judged Arm A - Ivonescimab and chemotherapy to be a 3 on the safety scale due to existent evidence of efficacy and numerous assessments verifying its security."

Answered by AI

How many hospitals within the U.S. are currently administering this clinical research?

"South Florida Oncology & Hematology Consultants LLC - Plantation in Plantation, Florida, Park Nicollet Institute in Saint Paul, Minnesota and Tranquil Clinical Research in Webster, Texas are amongst the clinical trial sites for this research. There are 4 additional locations as well."

Answered by AI

How many individuals are enrolled in this clinical experiment?

"Summit Therapeutics has announced that it requires 400 eligible patients to complete the medical trial. The study will be conducted across multiple sites, including South Florida Oncology & Hematology Consultants LLC - Plantation in Plantation, Florida and Park Nicollet Institute in Saint Paul, Minnesota."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Clinical Study of Ivonescimab for First-line Treatment of Metastatic Squamous NSCLC Patients

2023. "Clinical Study of Ivonescimab for First-line Treatment of Metastatic Squamous NSCLC Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05899608.

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